Health Resources and Services Administration; Organ Procurement and Transplantation Network Status of Living Donor Guidelines, 3519-3520 [E6-661]

Download as PDF Federal Register / Vol. 71, No. 14 / Monday, January 23, 2006 / Notices November 10, 2005), the per diem rates are being changed in the following locations: District of Columbia • Washington, District of Columbia; Arlington, Fairfax and Loudoun counties in the State of Virginia; Montgomery and Prince Georges counties in the State of Maryland. State of Arizona • Coconino County (except the city of Sedona) • Pima County State of California • Los Angeles, Orange, and Ventura Counties, Edwards Air Force Base • Santa Barbara County State of Colorado • Denver, Adams, Arapahoe, Jefferson and Douglas Counties State of Florida • Escambia County State of Illinois •Will County State of Maine • York County State of Maryland • Frederick County State of Michigan • Wayne County State of Minnesota • Dakota County State of Montana • Lewis and Clark County State of Nevada • Douglas and Carson City Counties State of New Mexico • Taos County State of Tennessee • Anderson County State of Texas • El Paso County B. Procedures erjones on PROD1PC61 with NOTICES Per diem rates are published on the Internet at www.gsa.gov/perdiemas FTR Per Diem Bulletins, notice of which is published in the Federal Register on a periodic basis. This process ensures timely increases or decreases in per diem rates established by GSA for Federal employees on official travel within CONUS. Notices published periodically in the Federal Register, such as this one, now constitute the only notification of revisions in CONUS per diem rates to agencies. Dated: January 17, 2006. Becky Rhodes, Deputy Associate Administrator.Office of Transportation and Personal Property. [FR Doc. 06–613 Filed 1–20–06; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Centers for Disease Control and Prevention Advisory Council for the Elimination of Tuberculosis Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Pregnancy Risk Assessment Monitoring System, Request for Applications DP–06–002 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following council meeting. Name: Advisory Council for the Elimination of Tuberculosis (ACET). Times and Dates: 8:30 a.m.–5 p.m., February 15, 2006. 8:30 a.m.–12 p.m., February 16, 2006. Place: Corporate Square, Building 8, 1st Floor Conference Room, Atlanta, Georgia 30333, telephone (404) 639–8008. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. Purpose: This council advises and makes recommendations to the Secretary, Department of Health and Human Services; the Assistant Secretary for Health; and the Director, Centers for Disease Control and Prevention (CDC) regarding the elimination of tuberculosis (TB). Specifically, the council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating TB. Matters to be Discussed: Agenda items include issues pertaining to TB Health Disparities among African Americans, TB prevention in correctional facilities, and other related TB issues. Agenda items are subject to change as priorities dictate. For Further Information Contact: Paulette Ford-Knights, National Center for HIV, STD, and TB Prevention, 1600 Clifton Road, NE., M/S E–07, Atlanta, Georgia 30333, telephone (404)639–8008. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: January 13, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–695 Filed 1–20–06; 8:45 am] BILLING CODE 4163–18–P 13:01 Jan 20, 2006 Jkt 208001 PO 00000 Frm 00066 Fmt 4703 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting: Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Pregnancy Risk Assessment Monitoring System, Request for Applications DP–06–002. Times and Dates: 3 p.m.–7:30 p.m., February 15, 2006 (Closed). 8 a.m.–5 p.m., February 16, 2006 (Closed). 8 a.m.–3 p.m., February 17, 2006 (Closed). Place: Sheraton Colony Square Hotel, 188 14th Street, NE., Atlanta, GA 30361, Telephone Number (404) 892–6000. Status: The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters to be Discussed: The meeting will include the review, discussion, and evaluation of applications received in response to: Pregnancy Risk Assessment Monitoring System, Request for Applications DP–06–002. For Further Information Contact: J. Felix Rogers, PhD, MPH, Scientific Review Administrator, CDC, 4770 Buford Highway, NE., Mailstop K–92, Atlanta, GA 30341, Telephone Number (770) 488–6521. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: January 13, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6–693 Filed 1–20–06; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration; Organ Procurement and Transplantation Network Status of Living Donor Guidelines Health Resources and Services Administration (HRSA), HHS. AGENCY: BILLING CODE 6820–14–S VerDate Aug<31>2005 3519 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1 3520 erjones on PROD1PC61 with NOTICES ACTION: Federal Register / Vol. 71, No. 14 / Monday, January 23, 2006 / Notices Request for public comment. SUMMARY: The purpose of this solicitation of comments is to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies. DATES: Written comments must be submitted to the office in the address section below by mail or e-mail on or before February 22, 2006. ADDRESSES: Please send all written comments to James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Room 12C–06, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443–7577; fax (301) 594–6095; or e-mail: jburdick@hrsa.gov. FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 12C–06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443–7577; fax (301) 594–6095; or e-mail: jburdick@hrsa.gov. SUPPLEMENTARY INFORMATION: Congress has provided specific authority under Sections 372 of the Public Health Service (PHS) Act, as amended, 42 U.S.C. 274 for the creation of a national OPTN, which is, among other things, to facilitate a donor and recipient matching system; establish membership criteria and medical criteria for allocating donated organs; and provide opportunities to members of the public to comment with respect to proposed criteria. The OPTN Final Rule (42 CFR part 121) governs the operations of the OPTN and is intended to help achieve the most equitable and medically effective use of human organs that are donated in trust for transplantation. Under the final rule, the OPTN is to develop policies on a variety of issues, including ‘‘[p]olicies for the equitable allocation of cadaveric organs [now referred to as deceased donor organs].’’ 42 CFR 121.4(a)(1). Under the final rule, allocation policies developed by the OPTN under section 121.8 of the final rule will be considered enforceable when and if the Secretary approves the policies as such. Enforceable OPTN policies are subject to the sanctions described in section 121.10(c)(1) of the final rule. Non- VerDate Aug<31>2005 13:01 Jan 20, 2006 Jkt 208001 enforceable OPTN policies may still be subject to lesser sanctions by the OPTN (e.g., an OPTN member being designated a member not in good standing). Although the authorizing statute does not distinguish between transplants using organs from living donors from those using organs from deceased donors, the final rule does not include a requirement that the OPTN develop policies concerning the equitable allocation of living donor organs. Until recently, OPTN policies have predominantly focused on issues related to organ donation and transplantation of deceased donor organs. However, several widely publicized living donor deaths have caused the OPTN to implement new practices of reviewing and approving, on an advisory basis, the qualifications of living donor transplant programs. Additionally, the increased incidence of altruistic living donations has prompted the OPTN to consider policies that are patient-focused yet address the unique circumstances pertaining to the recovery and transplantation of living donor organs. Section 121.4(a)(6) of the final rule provides that the OPTN shall be responsible for developing policies on a variety of topics, including ‘‘[p]olicies on such matters as the Secretary directs.’’ In accordance with that authority, the Healthcare Systems Bureau directed the OPTN to develop allocation guidelines for organs from living donors and other policies necessary and appropriate to promote the safety and efficacy of living donor transplantation for the donor and recipient. It further advised the OPTN that all living donation policies (other than data reporting policies) should be considered as best practices or voluntary guidelines and not subject to regular OPTN sanctions (even those available with respect to violation of non-enforceable policies) until the public has had an opportunity to comment on the matter. The purpose of this solicitation of comments is to assist HRSA in determining whether OPTN living donor guidelines should be given the same status of other OPTN policies, i.e., be treated as policies developed in accordance with 42 CFR 121.8, and be subject to the same enforcement actions. If the Secretary decides these questions in the affirmative, OPTN policies relating to living donors would be treated the same as other OPTN policies developed in accordance with section 121.8 of the final rule. In other words, OPTN policies concerning living donors would not be considered enforceable policies under section 121.10 of the final rule, and violations of such PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 policies would not be subject to the sanctions described in section 121.10(c)(1), unless and until the Secretary approved such policies as enforceable. Dated: January 13, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6–661 Filed 1–20–06; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG–2006–23650] Meeting of the Office of Boating Safety’s Recreational Boating Safety Strategic Planning Panel Coast Guard, DHS. Notice of meeting. AGENCY: ACTION: SUMMARY: The Coast Guard’s Office of Boating Safety is sponsoring a panel of representatives of the recreational boating community to discuss strategic planning goals, objectives and strategies that the Coast Guard may use to improve recreational boating safety. This meeting is open to the public. DATES: The meeting will occur on Saturday, Sunday and Monday, February 4 through 6, 2006, from 8:30 a.m. to 5 p.m. ADDRESSES: This meeting will occur at the Crowne Plaza Hotel, 1480 Crystal Drive, Arlington, VA. This notice is available on the Internet at http:// dms.dot.gov and at http:// uscgboating.org. FOR FURTHER INFORMATION CONTACT: Dionca Williams, Administrative Assistant, Office of Boating Safety, U.S. Coast Guard, telephone 202–267–1077, fax 202–267–4285. If you have questions on viewing material in the docket, call Renee V. Wright, Program Manager, Docket Operations, Department of Transportation, telephone 202–493– 0402. SUPPLEMENTARY INFORMATION: At the October 2004 meeting of the National Boating Safety Advisory Council (NBSAC), the Office of Boating Safety proposed to assemble a GoalSetting Recommendation Panel. NBSAC endorsed this proposal. To facilitate this, the Coast Guard invited representatives of the recreational boating community to participate on this panel. The Coast Guard held the meeting on February 8 and 9, 2005, in Arlington, VA. The panel considered, analyzed, E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 71, Number 14 (Monday, January 23, 2006)]
[Notices]
[Pages 3519-3520]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Health Resources and Services Administration; Organ Procurement 
and Transplantation Network Status of Living Donor Guidelines

AGENCY: Health Resources and Services Administration (HRSA), HHS.

[[Page 3520]]


ACTION: Request for public comment.

-----------------------------------------------------------------------

SUMMARY: The purpose of this solicitation of comments is to assist HRSA 
in determining whether criteria developed by the Organ Procurement and 
Transplantation Network (OPTN) concerning organs procured from living 
donors, including those concerning the allocation of organs from living 
donors, should be given the same status, and be subject to the same 
enforcement actions, as other OPTN policies.

DATES: Written comments must be submitted to the office in the address 
section below by mail or e-mail on or before February 22, 2006.

ADDRESSES: Please send all written comments to James F. Burdick, M.D., 
Director, Division of Transplantation, Healthcare Systems Bureau, 
Health Resources and Services Administration, Room 12C-06, Parklawn 
Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 
443-7577; fax (301) 594-6095; or e-mail: jburdick@hrsa.gov.

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, 
Division of Transplantation, Healthcare Systems Bureau, Health 
Resources and Services Administration, Parklawn Building, Room 12C-06, 
5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443-7577; 
fax (301) 594-6095; or e-mail: jburdick@hrsa.gov.

SUPPLEMENTARY INFORMATION: Congress has provided specific authority 
under Sections 372 of the Public Health Service (PHS) Act, as amended, 
42 U.S.C. 274 for the creation of a national OPTN, which is, among 
other things, to facilitate a donor and recipient matching system; 
establish membership criteria and medical criteria for allocating 
donated organs; and provide opportunities to members of the public to 
comment with respect to proposed criteria.
    The OPTN Final Rule (42 CFR part 121) governs the operations of the 
OPTN and is intended to help achieve the most equitable and medically 
effective use of human organs that are donated in trust for 
transplantation. Under the final rule, the OPTN is to develop policies 
on a variety of issues, including ``[p]olicies for the equitable 
allocation of cadaveric organs [now referred to as deceased donor 
organs].'' 42 CFR 121.4(a)(1). Under the final rule, allocation 
policies developed by the OPTN under section 121.8 of the final rule 
will be considered enforceable when and if the Secretary approves the 
policies as such. Enforceable OPTN policies are subject to the 
sanctions described in section 121.10(c)(1) of the final rule. Non-
enforceable OPTN policies may still be subject to lesser sanctions by 
the OPTN (e.g., an OPTN member being designated a member not in good 
standing).
    Although the authorizing statute does not distinguish between 
transplants using organs from living donors from those using organs 
from deceased donors, the final rule does not include a requirement 
that the OPTN develop policies concerning the equitable allocation of 
living donor organs. Until recently, OPTN policies have predominantly 
focused on issues related to organ donation and transplantation of 
deceased donor organs.
    However, several widely publicized living donor deaths have caused 
the OPTN to implement new practices of reviewing and approving, on an 
advisory basis, the qualifications of living donor transplant programs. 
Additionally, the increased incidence of altruistic living donations 
has prompted the OPTN to consider policies that are patient-focused yet 
address the unique circumstances pertaining to the recovery and 
transplantation of living donor organs. Section 121.4(a)(6) of the 
final rule provides that the OPTN shall be responsible for developing 
policies on a variety of topics, including ``[p]olicies on such matters 
as the Secretary directs.'' In accordance with that authority, the 
Healthcare Systems Bureau directed the OPTN to develop allocation 
guidelines for organs from living donors and other policies necessary 
and appropriate to promote the safety and efficacy of living donor 
transplantation for the donor and recipient. It further advised the 
OPTN that all living donation policies (other than data reporting 
policies) should be considered as best practices or voluntary 
guidelines and not subject to regular OPTN sanctions (even those 
available with respect to violation of non-enforceable policies) until 
the public has had an opportunity to comment on the matter.
    The purpose of this solicitation of comments is to assist HRSA in 
determining whether OPTN living donor guidelines should be given the 
same status of other OPTN policies, i.e., be treated as policies 
developed in accordance with 42 CFR 121.8, and be subject to the same 
enforcement actions. If the Secretary decides these questions in the 
affirmative, OPTN policies relating to living donors would be treated 
the same as other OPTN policies developed in accordance with section 
121.8 of the final rule. In other words, OPTN policies concerning 
living donors would not be considered enforceable policies under 
section 121.10 of the final rule, and violations of such policies would 
not be subject to the sanctions described in section 121.10(c)(1), 
unless and until the Secretary approved such policies as enforceable.

    Dated: January 13, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-661 Filed 1-20-06; 8:45 am]
BILLING CODE 4165-15-P